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Diagnosis of Periodontal Disease Using Genetic Marker in Saliva

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
non-surgical periodontal therapy
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Periodontitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A. Severe Periodontal Disease

  • Patients with chronic severe periodontitis
  • Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
  • subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing

A. Moderate Periodontal Disease

  • Patients with chronic moderate periodontitis
  • Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients.
  • subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing

C. Healthy Control

  • Healthy periodontal patients ( more than 20 permanent teeth are present , in all parts of deep periodontal pockets measuring 4mm or less, and height is 2mm or less clinical attachment person)
  • subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing

Exclusion Criteria:

  • Received periodontal treatment within the last six months
  • recently taken antibiotics within 3 months if you need a prescription antibiotic prophylaxis
  • taking the drug can affect periodontal status for a long period of time
  • pregnant or breastfeeding
  • In case of oral inflammatory mucosal disease (Lichen planus, etc.)
  • A history of alcoholism or drug abuse if
  • other special systemic disease (high blood pressure)
  • ages under 18

Sites / Locations

  • ASAN Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

severe periodontitis group

Moderate periodontitis group

healthy control

Arm Description

non-surgical periodontal therapy

non-surgical periodontal therapy

No treatment

Outcomes

Primary Outcome Measures

Expression level of MicroRNAs using Microarray

Secondary Outcome Measures

Expression level of cytokines using multiple cytokine analysis
Pro-inflammatory biomarker : interleukin(IL)-1a, IL-1b, IL-6, IL-8 Matrix metalloproteinase(MMP) : MMP-8, MMP-9 Anti-inflammatory biomarker: IL-10, inhibitor of MMP (TIMP)-1

Full Information

First Posted
February 19, 2014
Last Updated
February 20, 2014
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02069574
Brief Title
Diagnosis of Periodontal Disease Using Genetic Marker in Saliva
Official Title
Identification of Novel Periodontal Disease Biomarkers Using microRNA Expression in Saliva
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present study is to identify the novel periodontal disease biomarkers using differentially expressed microRNA in the saliva. The severity of chronic periodontal diseases and the time of pre- and post-treatment are major classification criteria. The obtained data will secure the foundation for the development of a new non-invasive diagnostic methods for early diagnosis & prognosis prediction of periodontal disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
severe periodontitis group
Arm Type
Experimental
Arm Description
non-surgical periodontal therapy
Arm Title
Moderate periodontitis group
Arm Type
Experimental
Arm Description
non-surgical periodontal therapy
Arm Title
healthy control
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal therapy
Primary Outcome Measure Information:
Title
Expression level of MicroRNAs using Microarray
Time Frame
Change from Baseline in expression level of MicroRNAs at 1,6,12 months
Secondary Outcome Measure Information:
Title
Expression level of cytokines using multiple cytokine analysis
Description
Pro-inflammatory biomarker : interleukin(IL)-1a, IL-1b, IL-6, IL-8 Matrix metalloproteinase(MMP) : MMP-8, MMP-9 Anti-inflammatory biomarker: IL-10, inhibitor of MMP (TIMP)-1
Time Frame
Change from Baseline in expression level of cytokines at 1,6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A. Severe Periodontal Disease Patients with chronic severe periodontitis Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients. subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing A. Moderate Periodontal Disease Patients with chronic moderate periodontitis Primary treatment of periodontal scaling, subgingival curettage is required, and the general progress of the protocol agreed with the basic periodontal therapy patients. subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing C. Healthy Control Healthy periodontal patients ( more than 20 permanent teeth are present , in all parts of deep periodontal pockets measuring 4mm or less, and height is 2mm or less clinical attachment person) subjects agreed collecting saliva and gingival crevicular fluid and physicochemical tests and genetic testing Exclusion Criteria: Received periodontal treatment within the last six months recently taken antibiotics within 3 months if you need a prescription antibiotic prophylaxis taking the drug can affect periodontal status for a long period of time pregnant or breastfeeding In case of oral inflammatory mucosal disease (Lichen planus, etc.) A history of alcoholism or drug abuse if other special systemic disease (high blood pressure) ages under 18
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Su-Hwan Kim, PhD.
Phone
82-2-3010-5797
Email
shkimperio@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su-Hwan Kim, PhD.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASAN Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su-Hwan Kim, PhD
Phone
82-2-3010-5797
Email
shkimperio@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Su-Hwan Kim, PhD

12. IPD Sharing Statement

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Diagnosis of Periodontal Disease Using Genetic Marker in Saliva

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